Teaching dermatology to medical students: a Scoping Review of published interventional studies.

It is unclear how dermatology should be optimally taught to medical students. Therefore, this scoping review was conducted aiming to identify and structure all published interventional studies that investigated dermatological teaching approaches with medical students. The methodology of this scoping review followed the PRISMA Extension for Scoping Reviews. The databases Medline and Embase were searched without restriction until 30.06.2020. A categorization and a descriptive analysis of the studies published as full articles were performed. The database search yielded 36,627 hits. 114 studies met all inclusion criteria. These came from 19 countries, were mainly published since 2010 and were distributed across 64 different journals. 32 randomized controlled trials were identified. A wide variety of teaching approaches was found, including both E-learning and conventional teaching formats. The results of the studies are presented in structured tables. This scoping review documents a large number of studies published worldwide on teaching dermatology to medical students. The teaching of dermatology appears to be successful with numerous teaching approaches, whereby interventions that incorporate didactic principles were verifiably more successful. This literature review can serve as an aid for evidence-based teaching design in dermatology as well as a basis for future research approaches.

Interventions for mycosis fungoides.

BACKGROUND: Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma, a malignant, chronic disease initially affecting the skin. Several therapies are available, which may induce clinical remission for a time. This is an update of a Cochrane Review first published in 2012: we wanted to assess new trials, some of which investigated new interventions. OBJECTIVES: To assess the effects of interventions for MF in all stages of the disease. SEARCH METHODS: We updated our searches of the following databases to May 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched 2 trials registries for additional references. For adverse event outcomes, we undertook separate searches in MEDLINE in April, July and November 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) of local or systemic interventions for MF in adults with any stage of the disease compared with either another local or systemic intervention or with placebo. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. The primary outcomes were improvement in health-related quality of life as defined by participants, and common adverse effects of the treatments. Key secondary outcomes were complete response (CR), defined as complete disappearance of all clinical evidence of disease, and objective response rate (ORR), defined as proportion of patients with a partial or complete response. We used GRADE to assess the certainty of evidence and considered comparisons of psoralen plus ultraviolet A (PUVA) light treatment as most important because this is first-line treatment for MF in most guidelines. MAIN RESULTS: This review includes 20 RCTs (1369 participants) covering a wide range of interventions. The following were assessed as either treatments or comparators: imiquimod, peldesine, hypericin, mechlorethamine, nitrogen mustard and intralesional injections of interferon-α (IFN-α) (topical applications); PUVA, extracorporeal photopheresis (ECP: photochemotherapy), and visible light (light applications); acitretin, bexarotene, lenalidomide, methotrexate and vorinostat (oral agents); brentuximab vedotin; denileukin diftitox; mogamulizumab; chemotherapy with cyclophosphamide, doxorubicin, etoposide, and vincristine; a combination of chemotherapy with electron beam radiation; subcutaneous injection of IFN-α; and intramuscular injections of active transfer factor (parenteral systemics). Thirteen trials used an active comparator, five were placebo-controlled, and two compared an active operator to observation only. In 14 trials, participants had MF in clinical stages IA to IIB. All participants were treated in secondary and tertiary care settings, mainly in Europe, North America or Australia. Trials recruited both men and women, with more male participants overall. Trial duration varied from four weeks to 12 months, with one longer-term study lasting more than six years. We judged 16 trials as at high risk of bias in at least one domain, most commonly performance bias (blinding of participants and investigators), attrition bias and reporting bias. None of our key comparisons measured quality of life, and the two studies that did presented no usable data. Eighteen studies reported common adverse effects of the treatments. Adverse effects ranged from mild symptoms to lethal complications depending upon the treatment type. More aggressive treatments like systemic chemotherapy generally resulted in more severe adverse effects. In the included studies, CR rates ranged from 0% to 83% (median 31%), and ORR ranged from 0% to 88% (median 47%). Five trials assessed PUVA treatment, alone or combined, summarised below. There may be little to no difference between intralesional IFN-α and PUVA compared with PUVA alone for 24 to 52 weeks in CR (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.87 to 1.31; 2 trials; 122 participants; low-certainty evidence). Common adverse events and ORR were not measured. One small cross-over trial found once-monthly ECP for six months may be less effective than twice-weekly PUVA for three months, reporting CR in two of eight participants and ORR in six of eight participants after PUVA, compared with no CR or ORR after ECP (very low-certainty evidence). Some participants reported mild nausea after PUVA but no numerical data were given. One participant in the ECP group withdrew due to hypotension. However, we are unsure of the results due to very low-certainty evidence. One trial comparing bexarotene plus PUVA versus PUVA alone for up to 16 weeks reported one case of photosensitivity in the bexarotene plus PUVA group compared to none in the PUVA-alone group (87 participants; low-certainty evidence). There may be little to no difference between bexarotene plus PUVA and PUVA alone in CR (RR 1.41, 95% CI 0.71 to 2.80) and ORR (RR 0.94, 95% CI 0.61 to 1.44) (93 participants; low-certainty evidence). One trial comparing subcutaneous IFN-α injections combined with either acitretin or PUVA for up to 48 weeks or until CR indicated there may be little to no difference in the common IFN-α adverse effect of flu-like symptoms (RR 1.32, 95% CI 0.92 to 1.88; 82 participants). There may be lower CR with IFN-α and acitretin compared with IFN-α and PUVA (RR 0.54, 95% CI 0.35 to 0.84; 82 participants) (both outcomes: low-certainty evidence). This trial did not measure ORR. One trial comparing PUVA maintenance treatment to no maintenance treatment, in participants who had already had CR, did report common adverse effects. However, the distribution was not evaluable. CR and OR were not assessable. The range of treatment options meant that rare adverse effects consequently occurred in a variety of organs. AUTHORS' CONCLUSIONS: ​​There is a lack of high-certainty evidence to support decision making in the treatment of MF. Because of substantial heterogeneity in design, missing data, small sample sizes, and low methodological quality, the comparative safety and efficacy of these interventions cannot be reliably established on the basis of the included RCTs. PUVA is commonly recommended as first-line treatment for MF, and we did not find evidence to challenge this recommendation. There was an absence of evidence to support the use of intralesional IFN-α or bexarotene in people receiving PUVA and an absence of evidence to support the use of acitretin or ECP for treating MF. Future trials should compare the safety and efficacy of treatments to PUVA, as the current standard of care, and should measure quality of life and common adverse effects.

Adaptation and validation of the Berlin questionnaire of competence in evidence-based dentistry for dental students: a pilot study.

BACKGROUND: The purpose of this pilot study was to create a valid and reliable set of assessment questions for examining Evidence-based Dentistry (EbD) knowledge. For this reason, we adapted and validated for dental students the Berlin Questionnaire (BQ), which assesses Evidence-based Medicine (EbM) abilities. METHODS: The Berlin Questionnaire was validated with medical residents. We adapted it for use in a dentistry setting. An expert panel reviewed the adapted BQ for content validity. A cross-sectional cohort representing four training levels (EbD-novice dental students, EbD-trained dental students, dentists, and EbM-/EbD-expert faculty) completed the questionnaire. A total of 140 participants comprised the validation set. Internal reliability, item difficulty and item discrimination were assessed. Construct validity was assessed by comparing the mean total scores of students to faculty and comparing proportions of students and faculty who passed each item. RESULTS: Among the 133 participants (52 EbD-novice dental students, 53 EbD-trained dental students, 12 dentists, and 16 EbM-/ EbD-expert faculty), a statistically significant (p < 0.001) difference was evident in the total score corresponding to the training level. The total score reliability and psychometric properties of items modified for discipline-specific content were acceptable. Cronbach's alpha was 0.648. CONCLUSION: The adapted Berlin Questionnaire is a reliable and valid instrument to assess competence in Evidence-based Dentistry in dental students. Future research will focus on refining the instrument further.

Semen cryopreservation in adolescent and adult men undergoing fertility compromising cancer treatment: A systematic review.

Treatment-related infertility is a common problem in cancer survivors. Semen cryopreservation is the most established option for male oncological patients wishing to preserve their fertility. We conducted a systematic review to analyse the existing literature regarding the frequency of offers and attempts of semen cryopreservation. We systematically searched MEDLINE and EMBASE for eligible literature without restrictions to language, study type or year of publication. Two authors independently screened and evaluated the citations for eligibility. Studies were included if they reported on pubertal or post-pubertal patients at risk of fertility impairment prior to their cancer therapy. We excluded studies neither reporting the prevalence of offer nor attempt of semen cryopreservation. Possible factors for heterogeneity between the studies were examined by meta-regression analyses. Out of 6,105 returned citations, 42 studies were included in the analysis. The prevalence of offer varied from 8% to 100% and corresponding attempts ranged from 3% to 79%, showing a vast heterogeneity with inconsistent reporting of influencing variables. Measured by the number of scientific publications, the awareness for fertility preservation is increasing while actual prevalences are diverse. In order to identify variables influencing offer and attempt prevalences, consistent reporting of a core set of factors is required.

Two-year analysis of dermatological out-of-hours consultations at Frankfurt University Hospital.

BACKGROUND: In recent years, emergency consultations have become more common in all medical disciplines. In Germany, dermatological out-of-hours consultations are handled by emergency practices, emergency departments and tertiary care providers. Little information is available on the reasons for these dermatological consultations. OBJECTIVES: The aim of this study was to analyze patient characteristics, diagnoses and admission rates resulting from these consultations. METHODS: We conducted a retrospective study covering two years of out-of-hours consultations at a dermatological tertiary referral center. RESULTS: A total of 3635 patients presented at the referral center. The most frequent outpatient diagnoses were acute urticaria (13.8 %) and bacterial infections (12.3 %). 83 % of the outpatient diagnoses required the most advanced competence level according to the new German curriculum for undergraduate education of medical students. 405 (11.01 %) patients did not require dermatological treatment, and 430 patients (13.6 %) were admitted to hospital. Most admissions were due to bacterial infections and herpes zoster. Advanced age, pain and fever were associated with a relatively high risk of admission. CONCLUSIONS: Admission rates at the dermatological tertiary referral center were substantially lower than at interdisciplinary emergency departments. A few diagnoses accounted for more than half of all consultations. These diagnoses are well represented within the new German curriculum.

S2k guidelines for the treatment of psoriasis in children and adolescents - Short version part 1.

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part 1 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part 2 will be published in the next issue. It contains chapters on UV therapy, systemic treatment, tonsillectomy and antibiotics, vaccinations, guttate psoriasis, psoriatic arthritis, complementary medicine, as well as imaging studies and diagnostic workup to rule out tuberculosis prior to systemic treatment.

S2k guidelines for the treatment of psoriasis in children and adolescents - Short version part 2.

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part 2 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part 1 was published in last month's issue. It contained introductory remarks and addressed aspects of diagnosis and topical treatment.

Laryngeal mask airway versus endotracheal tube for percutaneous dilatational tracheostomy in critically ill adults.

BACKGROUND: Percutaneous dilatational tracheostomy (PDT) is one of the most common bedside surgical procedures performed in critically ill adults, on intensive care units (ICUs), who require long-term ventilation. PDT is associated with relevant life-threatening complications: Cuff rupture or accidental extubation may lead to hypoxia, aspiration or loss of airway. Puncture of the oesophagus, or creating a false passage during dilatation or replacement of the tracheostomy tube, can lead to pneumothorax or emphysema. Wound infections may occur which can cause mediastinits, especially after creation of false passage or in early tracheotomized post-sternotomy patients after cardiac surgery. During the procedure, the patient's airway can be secured with an endotracheal tube (ETT) or a laryngeal mask airway (LMA). This is an updated version of the review first published in 2014. OBJECTIVES: To assess the safety and effectiveness of LMA versus ETT in critically ill adults undergoing PDT on the ICU. SEARCH METHODS: We searched the following databases to 9 January 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase. We searched for reports of ongoing trials in the metaRegister of Controlled Trials (mRCT). We handsearched for relevant studies in conference proceedings of five relevant annual congresses. We contacted study authors and experts concerning unpublished data and ongoing trials. We searched for further relevant studies in the reference lists of all included trials and of relevant systematic reviews. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared use of laryngeal mask airways versus endotracheal tubes in critically ill adults undergoing elective PDT in the ICU, without injuries to or diseases of the face or neck. We imposed no restrictions with regard to language, timing or technique of PDT performed. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility and methodological quality of each study and carried out data extraction. Our primary outcomes were all-cause mortality, procedure-related mortality and tally of participants with one or more serious adverse events. Where possible, we combined homogeneous studies for meta-analysis. We used Cochrane's 'Risk of bias' tool and used GRADE to assess the quality of evidence for key outcomes. MAIN RESULTS: We included nine RCTs in this review involving 517 participants.Studies had a high or unclear risk of bias. The main reason for this was low methodological quality or missing data, even after study authors were contacted. Study size was generally small, with a minimum of 40, and a maximum of 73 participants.In one study (40 participants), three deaths in the LMA group and two deaths in the ETT group were reported, although none of the deaths were related to the procedure (very low-quality evidence).Five studies (281 participants) reported on procedure-related deaths, stating that no procedure-related death occurred at all (very low-quality evidence).It is uncertain whether there is a difference in the number of people experiencing one or more serious adverse event(s) between LMA and ETT (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.41 to 1.80; 467 participants, 8 studies, very low-quality evidence).The duration of the procedure may be shorter in the LMA group (mean difference (MD) -1.46 minutes, 95% CI -1.92 to -1.01 minutes; 6 studies, 324 participants, low-quality evidence).However failure of procedure, as allocated by randomization, requiring conversion to any other procedure, may be higher in the LMA group (RR 2.82, 95% CI 1.22 to 6.52; 8 studies, 439 participants, low-quality evidence).We did not find any clear evidence of a difference between ETT and LMA groups for all other outcomes. Only one study provided follow-up data for late complications related to the intervention, showing no clear evidence of benefit for any treatment group. AUTHORS' CONCLUSIONS: Evidence on the safety of LMA for PDT is too limited to allow conclusions to be drawn on either its efficacy or safety compared with ETT. Although the LMA procedure may shorten the period during which the airway is insecure, it may also lead to higher conversion rates. Also, late complications have not been investigated sufficiently. These results are primarily based on single-centre trials with small sample sizes, and therefore the level of evidence remains low. Studies with low risk of bias focusing on late complications and relevant patient-related outcomes are necessary for definitive conclusions on safety issues related to this procedure. The dependency of the successful placement of a LMA on the type of LMA used should also be further assessed.There are two studies awaiting classification that may alter the conclusions once assessed.

S1 Guidelines - Dermatoses associated with dermal lymphostasis.

The objective of the present S1 guidelines is to present current knowledge about dermatologically relevant diseases associated with localized dermal lymphostasis, thus facilitating their early detection, diagnostic workup, and targeted treatment. Whenever possible, treatment should be based on stage-appropriate and clearly defined algorithms. The numerous issues regarding differential diagnosis and treatment clinicians are confronted with in everyday clinical practice seem to warrant the publication of up-to-date guidelines. These guidelines focus on patients of all age groups and genders exhibiting skin lesions caused by dermal lymphostasis. Specific recommendations are provided with respect to the diagnosis and differential diagnosis of the various clinical manifestations. In this context, comorbid skin diseases such as atopic dermatitis, psoriasis, hidradenitis suppurativa, urticaria, and contact dermatitis will be highlighted, including their treatment and associated specific risks. Several other relevant current guidelines are referenced as regards the distinction from and treatment of common cofactors and comorbid conditions.

S1-Leitlinie - Dermatosen bei dermaler Lymphostase.

Das Ziel dieser S1-Leitlinie ist es, aktuelles Wissen über dermatologisch relevante Krankheitsbilder bei lokal begrenzter dermaler Lymphostase an allen Lokalisationen des Hautorgans zu vermitteln, um diese frühzeitig zu erkennen, diagnostisch zu sichern und gezielt zu behandeln. Wann immer möglich, sollte diese Therapie anhand klar definierter Algorithmen stadiengerecht erfolgen. Die im klinischen Alltag häufig auftauchenden differenzialdiagnostischen und therapeutischen Fragen lassen eine aktuelle Leitlinie notwendig erscheinen. Diese Leitlinie fokussiert auf Patienten jeglichen Alters und Geschlechts mit Hautveränderungen, die im kausalen Zusammenhang mit dermaler Lymphostase stehen. In konkreten Handlungsempfehlungen werden die Diagnostik und Differenzialdiagnostik der verschiedenen Manifestationsformen bei gleichzeitig auftretender dermatologischer Komorbidität wie beispielsweise atopische Dermatitis, Psoriasis vulgaris, Acne inversa, Urtikaria, Kontaktekzeme sowie ihre Therapien unter Berücksichtigung besonderer Risiken veranschaulicht. Für die Abgrenzung und Behandlung häufiger therapierelevanter Kofaktoren und Komorbidität wird auf mehrere andere hierfür relevante aktuelle Leitlinien verwiesen.

S3-Leitlinie zur Therapie der Psoriasis vulgaris Update - Kurzfassung Teil 2 - Besondere Patientengruppen und spezielle Behandlungssituationen.

Die deutsche Psoriasis-Leitlinie zur Behandlung der Psoriasis vulgaris wurde unter Verwendung der GRADE-Methodik aktualisiert. Die Leitlinie wurde aufbauend auf einer systematischen Literaturrecherche (letzte Update-Recherche am 01.12.2016) entwickelt und in einem formalen Konsensus- und Freigabeverfahren verabschiedet. Der zweite Teil dieser Kurzfassung stellt die Empfehlungen zum Tuberkulose-Screening vor und unter Therapie, zur Therapieauswahl bei Kinderwunsch, Schwangerschaft und Stillzeit, vorliegender Gelenkbeteiligung sowie zum Umgang mit Impfungen dar. Zudem werden die Empfehlungen zur Therapieauswahl bei Komorbidität mit Hepatitis und Leberfunktionseinschränkungen, HIV, Tumorerkrankungen, Erkrankungen aus dem neurologischen und psychiatrischen Formenkreis, koronarer Herzkrankheit und Herzinsuffizienz, Diabetes mellitus, Niereninsuffizienz sowie chronisch entzündlicher Darmerkrankung dargestellt.

S3 Guideline for the treatment of psoriasis vulgaris, update - Short version part 2 - Special patient populations and treatment situations.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a formal consensus and approval process. The second part of this short version of the guideline covers the following special patient populations and treatment situations: tuberculosis screening before and during psoriasis treatment, choice of psoriasis treatment for individuals wishing to have children, as well as during pregnancy and breast-feeding, and patients with joint involvement and vaccinations. In addition, recommendations on the choice of treatment are presented for patients with the following comorbidities: hepatitis and other hepatic impairment, HIV, malignancies, neurological and psychiatric disorders, ischemic heart disease and congestive heart failure, diabetes mellitus, renal impairment and inflammatory bowel disease.

S3 Guideline for the treatment of psoriasis vulgaris, update - Short version part 1 - Systemic treatment.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a formal consensus and approval process. The first section of this short version of the guideline covers systemic treatment options considered relevant by the expert panel and approved in Germany at the time of the consensus conference (acitretin, adalimumab, apremilast, cyclosporine, etanercept, fumaric acid esters, infliximab, methotrexate, secukinumab and ustekinumab). Detailed information is provided on the management and monitoring of the included treatment options.

German guidelines for the diagnosis and therapy of localized scleroderma.

Localized scleroderma designates a heterogeneous group of sclerotic skin disorders. Depending on the subtype, severity, and site affected, adjacent structures such as adipose tissue, muscles, joints, and bones may be involved. This is an update of the existing German AWMF (Association of the Scientific Medical Societies in Germany) guidelines (classification: S2k). These guidelines provide an overview of the definition, epidemiology, classification, pathogenesis, laboratory workup, histopathology, clinical scoring systems, as well as imaging and device-based workup of localized scleroderma. Moreover, consensus-based recommendations are given on the management of localized scleroderma depending on its clinical subtype. Treatment recommendations are presented in a therapeutic algorithm. No financial support was given by any pharmaceutical company. The guidelines are valid until July 2019.

Laryngeal mask airway versus endotracheal tube for percutaneous dilatational tracheostomy in critically ill adult patients.

BACKGROUND: Percutaneous dilatational tracheostomy (PDT) is one of the most common bedside surgical procedures performed in critically ill adult patients on intensive care units (ICUs) who require long-term ventilation. PDT is generally associated with relevant life-threatening complications (e.g. cuff rupture leading to possible hypoxia or aspiration, puncture of the oesophagus, accidental extubation, mediastinitis, pneumothorax, emphysema). The patient's airway can be secured with an endotracheal tube (ETT) or a laryngeal mask airway (LMA). OBJECTIVES: To assess the safety and effectiveness of ETT versus LMA in critically ill adult patients undergoing PDT on the ICU.This review addresses the following research questions.1. Is an LMA more effective than an ETT in terms of procedure-related or all-cause mortality?2. Is an LMA safer than an ETT in terms of procedure-related life-threatening complications during a PDT procedure?3. Does use of an LMA influence the conditions for performing a tracheostomy (e.g. duration of procedure)? SEARCH METHODS: We searched the Cochrane Database of Systematic Reviews (CDSR); the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 6 (part ofThe Cochrane Library); MEDLINE (from 1984 to 27 June 2013) and EMBASE (from 1984 to 27 June 2013). We searched for reports of ongoing trials in the metaRegister of Controlled Trials (mRCT). We handsearched for relevant studies in conference proceedings of the International Symposium on Intensive Care and Emergency Medicine (ISICEM), the Annual Congress of the European Society of Intensive Care Medicine (ESICM), the Annual Congress of the Society of Critical Care Medicine (SCCM), the American Thoracic Society (ATS) and the Annual Meeting of the American College of Chest Physicians (ACCP). We contacted study authors and experts concerning unpublished data and ongoing trials. We searched for further relevant studies in the reference lists of all included trials and of relevant systematic reviews identified in theCDSR. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared use of endotracheal tubes versus laryngeal mask airways in critically ill adult patients undergoing PDT on the ICU. We imposed no restrictions with regard to language, timing or technique of PDT performed. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility and methodological quality of each study and carried out data extraction. We resolved disagreements by discussion. Our primary outcomes were all-cause mortality, procedure-related mortality and tally of participants with one or more serious adverse events. When available, we reported on our secondary outcomes, which included duration of the procedure, failure of the procedure requiring conversion to any other procedure, time to extubation after tracheostomy, length of ICU stay after tracheostomy, length of hospital stay after tracheostomy and any other serious adverse events. When possible, we combined homogeneous studies for meta-analysis. We used the risk of bias tool of The Cochrane Collaboration to assess the internal validity of all included studies in six different domains. MAIN RESULTS: We included in this review eight RCTs involving 467 participants. The included trials exclusively assessed critically ill participants (e.g. with head injury, neurological disease, multi-trauma, sepsis, acute respiratory failure (ARF) and/or chronic obstructive pulmonary disease (COPD)). Internal validity was considerably low in studies with a high or unclear risk of bias. The main reason for this was low methodological quality or missing data, even after study authors were contacted. Study size was generally small, with a minimum of 40 and a maximum of 73 participants. Only one study (40 participants) reported on overall mortality, showing no clear evidence of a difference between treatment groups (risk ratio (RR) 1.5, 95% confidence interval (CI) 0.28 to 8.04, Fisher test P value 1.0, low-quality evidence). Four studies (231 participants) reported that no procedure-related deaths occurred with any intervention. Seven studies reported the numbers of participants with adverse events, showing no clear evidence of benefit of either LMA or ETT during PDT (RR 0.73, 95% CI 0.35 to 1.52, P value 0.41, low-quality evidence). The tally of participants in included studies with adverse events ranged from 0% to 33% in the LMA group and from 0% to 50% in the ETT group. However, the duration of the procedure was significantly shorter in the LMA group (mean difference (MD) -1.46 minutes, 95% CI -1.92 to -1.01 minutes, 324 participants, P value ≤ 0.00001, low-quality evidence). No clear evidence of a difference between ETT and LMA groups was found for all other outcomes. Only one study provided follow-up data for late complications related to the intervention, showing no clear evidence of benefit for any treatment group. AUTHORS' CONCLUSIONS: Evidence on the safety of LMA for PDT is too limited to allow conclusions to be drawn on its efficacy or safety compared with ETT. Although the LMA procedure is shorter because of optimal visual conditions, its effect on especially late complications has not been investigated sufficiently. Studies focusing on late complications and relevant patient-related outcomes are necessary for definitive conclusions on safety issues related to this procedure.